Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: TRC160334: TRC160334 2 mg tablet twice a day for 12 week
Intervention2: TRC160334: TRC160334 4 mg tablet twice a day for 12 week
Control Intervention1: Placebo: Matching Placebo
Sponsors
Torrent Pharmaceuticals Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects willing to give written informed consent to participate in the study. 2. Male and female subjects aged 18 to 60 years (both inclusive). 3. Subjects diagnosed with ulcerative colitis, confirmed by endoscopically and histologically not less than 6 weeks prior to baseline. 4. Subjects with active, mild to moderate disease as defined by Mayo score of 4-10 and sigmoidoscopy/colonoscopy score _ 1 (if colonoscopy has not been performed in past 1 year, it should be performed at the time of screening). 5. Subjects on stable dose of oral mesalamine at 2.4 gm/day or higher recommended dose as tolerated for 2 weeks prior to screening. 6. Subjects able to comprehend the study questionnaire and adhere to the study restrictions and assessments schedule.
Exclusion criteria
Exclusion criteria: 1. Subjects with inflammation confined to _ 15 cm from anal margin; diagnosis of Crohn’s disease, indeterminate colitis or at immediate or significant risk of toxic megacolon, previous colonic surgery or recent colonoscopy suggestive of dysplastic changes or colorectal cancer, presence of fistulae, or stenosis of the intestine. 2. Subjects who have received systemic or rectal steroids within last 4 weeks or rectal 5-ASA within 2 weeks prior to screening. 3. Subjects who have received an immunosuppressant such as azathioprine, methotrexate, 6-mercaptopurine, cyclosporine, tacrolimus or biologicals within 60 days prior to screening, or antibiotics within 2 weeks prior to screening, or those using anti-inflammatory drugs within 1 week prior to screening (with the exception of aspirin at doses up to 325 mg/day for cardio-protection, or paracetamol for mild acute pain, which are permitted throughout the study), or currently using any alternative or herbal medicines and refuses to discontinue. 4. Subjects with evidence of intestinal infection detected by positive stool culture for enteric pathogens, or Clostridium difficile or with ova and/or parasites (detected by microscopy). 5. Subjects with Hb 6. Subjects with liver enzymes (ALT, AST, ALP) > 3 times of upper limit of normal (ULN) or serum total bilirubin > 2 times of ULN, and considered clinically significant by Investigator. 7. Subjects with renal impairment (eGFR _ 60 mL/min/1.73 m2 by MDRD). 8. Participation in any interventional trial during last three months. 9. Pregnant or lactating women, or female of childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal, barrier methods or intrauterine device) or male subjects with partners of childbearing potential not willing to use reliable methods of contraception. 10. Subjects planning to undergo any elective surgical procedure during their participation in the study, which will have an impact on disease under evaluation(except minor procedures not associated with significant restriction of food and fluids). 11. Subject suffering from any other comorbid conditions or having clinically significant abnormal physical findings, laboratory results, ECG findings and/or any other clinical observation or history during the screening examination, which would interfere with the objectives of the study. 12. Seropositive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). 13. Current or history of alcohol or drug abuse within 1 year prior to randomization. 14. In the opinion of the Investigator, subject is unable to communicate with study team or follow their instructions, or unlikely to cooperate/adhere with any study procedures, or keep appointments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving clinical responseTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) DomainTimepoint: 12 weeks;Proportion of subjects achieving clinical remissionTimepoint: 12 weeks;Proportion of subjects requiring rescue medicationTimepoint: Through out the study;Time required to achieve one-point reduction from baseline in rectal bleeding Mayo subscoreTimepoint: Through out the study | — |
Countries
India
Contacts
Public ContactDr Ram Gupta
Torrent Pharmaceuticals Ltd.
Outcome results
None listed